Pain Education and Therapeutic Exercise for Fibromyalgia
NCT ID: NCT03641495
Last Updated: 2021-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2018-09-03
2019-01-30
Brief Summary
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The objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pain education plus exercise therapy (PE + ET)
Pain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
PE+ET
To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain.
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Exercise therapy (ET)
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
ET
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Interventions
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PE+ET
To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain.
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
ET
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed according to the American College of Rheumatology criteria
* Agreement to attend to treatment sessions
Exclusion Criteria
* Other kind of diseases that could limit the intervention
* Previous surgery last year
* Medication modifications in the last 3 months
18 Years
ALL
No
Sponsors
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University of Valladolid
OTHER
Universidad de Zaragoza
OTHER
Responsible Party
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Sandra Jiménez
Principal Investigator
Locations
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Sandra Jiménez del Barrio
Soria, , Spain
Countries
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Other Identifiers
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University of Valladolid
Identifier Type: -
Identifier Source: org_study_id
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